secwatch.observer — SEC 8-K summary
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Issuer:     Arcturus Therapeutics Holdings Inc. (ARCT)
CIK:        0001768224
Form:       8-K
Filed at:   2023-04-28T23:59:59+00:00
Accession:  0001193805-23-000619
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Meiji submits NDA in Japan for ARCT-154, Arcturus' self-amplifying mRNA COVID-19 vaccine
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- Meiji Seika Pharma filed NDA for primary immunization (two doses) of ARCT-154 in Japan.
- NDA based on Phase III trial in Vietnam (NCT05012943) with >16,000 subjects; met primary endpoint of COVID-19 prevention.
- Meiji holds exclusive Japan distribution rights from CSL Seqirus; Arcturus developed the vaccine.
- ARCT-154 uses next-gen mRNA technology for strong immune response and potential lower dosing.
- Meiji collaborates with ARCALIS to build mRNA manufacturing in Minami-soma, Fukushima.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1768224/000119380523000619/0001193805-23-000619-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1768224/000119380523000619/e618558_8k-arct.htm
  HTML page:      https://secwatch.observer/filing/0001193805-23-000619

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer